FDA recall Z-2530-2023

Product

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

Reason for recall

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Distribution

Distribution US nationwide, including Puerto Rico. OUS: Not provided

Key facts

Status

Ongoing

Initiation date

2023-07-26

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2023